ADC Therapeutics SA

Current report

Recent Developments

Current report

On June 24, 2026, we announced a strategic reorganization to focus resources behind key value-driving initiatives in support of ZYNLONTA. As part of the reorganization, we are reducing our global workforce by approximately 17%, which is expected to be substantially completed by September 30, 2026 (“2026 Restructuring”). The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. To ensure continuity during this transition, on June 30, 2026, our Board of Directors, with the advice of its independent compensation consultant, approved a one-time retention award to certain of our employees, including our named executive officers.

Current report

LOTIS-5 Clinical Trial Update

Current report

In June 2026 we announced topline data from our Phase 3 LOTIS-5 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”). ZYNLONTA plus rituximab achieved statistical significance on the trial’s primary endpoint of progression-free survival (“PFS”) and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival (“OS”). In addition, a higher complete response (“CR”) rate and duration of CRs (“DoCR”) were observed with ZYNLONTA plus rituximab. Overall, treatment emergent adverse event (“TEAE”) rates were similar between arms. Similar rates of overall Grade ≥3 TEAEs greater than 5% were observed across both arms, with hematologic TEAEs higher in the control arm and infection, hepatotoxicity (primarily increased Gamma-glutamyltransferase increased (GGT), and edema/effusion higher in the test arm. Serious adverse events (“SAEs”), TEAEs leading to study drug withdrawal, and Grade 5 events were higher in the test arm, with the majority of Grade 5 TEAEs in the test arm occurring in patients aged 75 years or older. We submitted full data to the 68th American Society of Hematology (“ASH”) Annual Meeting and Exposition.

Current report

The LOTIS-5 trial is a randomized, open‐label, two‐arm, multicenter study evaluating ZYNLONTA plus rituximab versus the standard immunochemotherapy rituximab gemcitabine‐oxaliplatin (R‐GemOx), for the treatment of r/r DLBCL after one or more lines of systemic therapy. The study met the primary endpoint of PFS (per independent review committee) with statistical significance (HR = 0.73; p-value = 0.008 two sided), with a median PFS of 6.1 months for ZYNLONTA plus rituximab vs 4.7 months for R-GemOx. Overall survival showed no detrimental effect with ZYNLONTA plus rituximab compared to the control arm (HR = 0.96, impacted by the earlier use and a higher rate of new anti-lymphoma treatment switching in the control arm). Overall response rate (“ORR”) was 58.1% vs. 45.2%, CR rate was 39.5% vs. 26.7%, median duration of response (DOR) was 9.2 months vs. 7.7 months, and median DoCR was 16.8 months vs. 12.3 months for ZYNLONTA plus rituximab compared to R-GemOx, respectively. Of patients achieving CR, 48.5% vs. 16.7% remained in CR at 24 months in favor of ZYNLONTA plus rituximab. Of note, results in North America were consistent with the overall study results.

Current report

Overall, TEAE rates were similar between arms (98.5% vs. 97.5%). Higher rates of SAEs were seen in the test arm (49.0% vs. 34.5%). Grade ≥3 TEAEs observed in > 5% of patients were hematologic (40.7% vs. 59.4%), followed by infection/ infestations (24.5% vs. 15.7%), then hepatotoxicity (primarily increased GGT) (17.2% vs. 8.1%) and oedema/effusion (7.4% vs. 0.5%) when comparing ZYNLONTA plus rituximab to R-GemOx. A higher rate of Grade 5 TEAEs was observed in the ZYNLONTA plus rituximab arm (27 pts/13.2%) vs. R-GemOx (9 pts/4.6%). Of note, the majority of Grade 5 TEAEs in the test arm occurred in patients aged 75 years or older. Higher rates of TEAEs leading to any drug withdrawal occurred in the ZYNLONTA plus rituximab arm (25.5% vs. 9.1%). In this study, the TEAE reporting window was defined as 105 days after the last dose of study treatment or the start of new anticancer therapy, whichever is earlier. The rates of TEAEs in this study were impacted by the longer overall TEAE observation time in the test vs. control arm (median 3.9 vs. 2.5 months). This difference is primarily driven by shorter treatment duration, a higher rate of and earlier switching to subsequent therapies and a higher rate of early withdrawal in the control arm.

Current report

We recently held a pre-sBLA meeting with the FDA. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in this trial based on the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit. Following this meeting, we are assessing the best regulatory path forward and plans to provide an update on regulatory strategy and timing in the future. ZYNLONTA remains under accelerated approval as a monotherapy in 3L+ DLBCL and we plan to continue to commercialize in this setting.

Current report

LOTIS-7 Clinical Trial Update

Current report

In June 2026 we announced the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI®) in 100 patients with r/r DLBCL. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis (including vaccinations) for viral, fungal, and bacterial infections (including PJP and herpesvirus), which was not a part of the LOTIS-5 protocol.

Current report

Enrollment occurred in 30 total sites with 70% of patients in the U.S. and 30% in the EU. The study enrolled patients with baseline characteristics similar to other bispecific combination studies in this space and included 46% relapsed and 54% primary refractory patients with a median age of 66 years.

Current report

Primary endpoints of the study include safety and tolerability. Secondary endpoints include ORR, duration of response, CRR, relapse free survival, PFS, and OS, as well as pharmacokinetics and immunogenicity. As part of the study protocol, anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing B-cell loss with an increased risk of infection) and vaccination are strongly recommended.

Current report

Previously reported data from this study demonstrated an 89.8% ORR and 77.6% CR and a manageable safety profile across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up. We submitted LOTIS-7 data to ASH. We are preparing to submit the complete trial results for publication, which will then be submitted to compendia. We are also evaluating a regulatory pathway for this combination and plan to submit for Breakthrough Therapy designation (“BTD”) this year.

Current report

The University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (“FL”) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (“MZL”) are ongoing. Updated MZL data were submitted to ASH and we anticipate presentation of this data before the end of the year with publication and compendia submission to follow. We also anticipate presentation of updated FL data in Q2 2027. We intend to assess potential regulatory pathways and plan to submit for BTD for MZL.

Current report

Product revenues, net, were $18.6 million for the three months ended June 30, 2026 as compared to $18.1 million for the three months ended June 30, 2025, an increase of $0.5 million, or 3.0%. The increase is primarily attributable to a higher price. Sales volume was consistent on a period over period basis.

Current report

License revenues and royalties were $0.6 million for the three months ended June 30, 2026 as compared to $0.8 million for the three months ended June 30, 2025. The decrease was attributable to decreased royalty revenue from our exclusive license agreement with SOBI to develop and commercialize ZYNLONTA in all territories other than the United States, greater China, Singapore and Japan.

Current report

General and administrative expenses were $9.7 million for the three months ended June 30, 2026 as compared to $8.8 million for the three months ended June 30, 2025, an increase of $0.9 million, or 10.0%. The increase in external costs and overhead of $0.9 million was primarily related to higher legal expenses of $0.5 million and higher IT expenses of $0.3 million. The decrease in employee expenses of $0.9 million was primarily due to lower wages and benefits. The increase in share-based compensation expense of $0.9 million was primarily due to higher grant date fair values of RSU awards issued during the year, driven by both an increased number of awards and stock price appreciation at the time of grant.

Current report

Restructuring, Impairment and Other Related Costs

Current report

In connection with the 2026 Restructuring, we incurred Restructuring, impairment, and other related costs of $2.7 million for the three months ended June 30, 2026, which consisted of severance and related benefit costs. We expect to pay the majority of the 2026 restructuring costs by the third quarter of 2026. In connection with the 2025 Restructuring, we incurred Restructuring, impairment, and other related costs of $13.1 million for the three months ended June 30, 2025, which consisted of $6.7 million in severance and related benefit costs and $6.4 million in impairment of long-lived assets and prepaid expenses. The 2025 Restructuring was complete as of June 30, 2026.

Current report

Cumulative catch-up adjustment income, deferred royalty obligation

Current report

We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income was $6.3 million for the three months ended June 30, 2026 as compared to $0.2 million for the three months ended June 30, 2025, a change of $6.1 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2026, as a result of changes in assumptions in the Company’s updated strategic and development plans.

Current report

Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025

Current report

Revenue

Current report

Product Revenues, net

Current report

License Revenues and Royalties

Current report

Operating Expenses

Current report

Cost of Product Sales

Current report

Research and Development Expenses

Current report

Our R&D expenses were $37.2 million for the six months ended June 30, 2026 as compared to $59.0 million for the six months ended June 30, 2025, a decrease of $21.8 million, or 36.9%.

Current report

The changes in employee and share-based compensation expenses were primarily driven by lower wages and benefits of $5.2 million resulting from the 2025 Restructuring, partially offset by higher temporary project help of $1.9 million. Additionally, we had a $3.8 million shift in personnel costs (including $0.7 million in share-based compensation expense) to cost of product sales ($2.3 million), inventory capitalization ($1.1 million) and selling and marketing expense ($0.4 million), reflecting a change in focus of these personnel from research and development activities to commercial manufacturing and fulfillment activities. These decreases were partially offset by higher share-based compensation expense due to the timing of forfeitures of awards in connection with employee terminations and higher grant date fair values of RSU awards issued during the year, driven by both an increased number of awards and stock price appreciation at the time of grant.

Current report

Selling and Marketing Expenses

Current report

General and Administrative Expenses

Current report

Restructuring, Impairment and Other Related Costs

Current report

In connection with the 2026 Restructuring, we incurred Restructuring, impairment, and other related costs of $2.7 million for the six months ended June 30, 2026, which consisted of severance and related benefit costs. We expect to pay the majority of the 2026 restructuring costs by the third quarter of 2026. In connection with the 2025 Restructuring, we incurred Restructuring, impairment, and other related costs of $13.1 million for the six months ended June 30, 2025, which consisted of $6.7 million in severance and related benefit costs and $6.4 million in impairment of long-lived assets and prepaid expenses. The 2025 Restructuring was complete as of June 30, 2026.

Current report

Other Income (Expense)

Current report

Interest Income

Current report

Interest income was $3.8 million for the six months ended June 30, 2026 as compared to $4.0 million for the six months ended June 30, 2025, a decrease of $0.2 million or 4.4%. The decrease was primarily due to lower yields received on our cash deposits.

Current report

HCR Warrants

Current report

Cumulative catch-up adjustment income, deferred royalty obligation

Current report

We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income was $6.4 million for the six months ended June 30, 2026 as compared to $0.2 million for the six months ended June 30, 2025, a change of $6.2 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2026, as a result of changes in assumptions in the Company’s updated strategic and development plans.

Current report

Income Tax Expense

Previous report

Interest Expense

Previous report

Other, net

Current report — wording carried from elsewhere

Phase 2 Investigator Initiated Trials (IITs) Update

Current report — wording carried from elsewhere

We generate license revenue and royalties from our strategic agreements for the development and commercialization of ZYNLONTA outside of the United States. Under these agreements, we receive upfront payments and are eligible for certain milestone payments and royalties. See “Item 1. Business—Material Contracts” in our Annual Report on Form 10-K.

Current report — wording carried from elsewhere

We are unable to predict the timing and amounts of license revenue and royalties as meeting milestones is subject to many factors outside of our control and we have limited control over our partners’ commercialization efforts.

Current report — wording carried from elsewhere

Selling and marketing expenses were $12.6 million for the three months ended June 30, 2026 as compared to $10.1 million for the three months ended June 30, 2025, an increase of $2.4 million, or 23.9%. The increase in external costs and overhead of $1.7 million was primarily attributable to higher spend on marketing and advertising expenses. The increase in employee and share-based compensation expenses were due to a $0.1 million increase in certain personnel costs, reflecting an increase in commercial fulfillment activities. The increase in share-based compensation expense was also driven by higher grant date fair values of RSU awards issued during the year, driven by both an increased number of awards and stock price appreciation at the time of grant.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. Our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration of patient therapy and customers’ ordering patterns, pricing and GTN deductions. We expect a relatively consistent level of GTN sales adjustments as a percentage of gross sales, but may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.

Current report — wording carried from elsewhere

Cost of product sales includes costs directly and indirectly relating to the manufacture of ZYNLONTA commercial drug substance and drug product, including the third-party manufacture costs of our contract manufacturing organizations (“CMOs”), as well as internal personnel costs, including share-based compensation, associated with the production of ZYNLONTA. Cost of product sales also includes royalties payable to a collaboration partner based on net product sales of ZYNLONTA, idle capacity costs, and inventory write-downs for changes in reserves for excess inventory or write-offs of inventory that fail to meet specification. We expect that cost of product sales will continue to increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation, tariffs and other external factors may also increase our cost of product sales.

Current report — wording carried from elsewhere

Cost of product sales were $6.0 million for the six months ended June 30, 2026 as compared to cost of product sales of $2.9 million for the six months ended June 30, 2025, an increase of $3.1 million, or 105.9%. The increase in cost of product sales was primarily attributable to a $2.5 million increase in certain personnel costs, reflecting a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities. Cost of product sales was also higher due to higher stability, shipping and storage charges for the six months ended June 30, 2026.

Current report — wording carried from elsewhere

The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

Research and development expense consists primarily of costs for production of preclinical and clinical-stage product candidates by CMOs; fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials; costs of related facilities, materials and equipment; external costs associated with obtaining intellectual property; depreciation; upfront fees and achieved milestone payments associated with R&D collaboration arrangements; and employee related expenses, including share-based compensation expense.

Current report — wording carried from elsewhere

We expect our research and development expense to decrease for fiscal year 2026, as compared to 2025, primarily driven by an expected reduction in spending on discontinued programs and our preclinical product candidates and research pipeline as a result of the 2025 Restructuring, as well as reduced spend on ZYNLONTA due to the timing, progress and stage of clinical trials. Thereafter, our research and development expense may fluctuate from period to period based on a number of factors, including the timing, progress and stage of clinical trials, costs associated with regulatory approval processes and manufacturing costs associated with commercialization activities prior to the receipt of regulatory approval.

Current report — wording carried from elsewhere

The decrease in external costs and overhead of $16.3 million was driven primarily by discontinued programs and our preclinical product candidates and research pipeline as a result of the 2025 Restructuring and completion of IND-enabling activities for our PSMA-targeting ADC.

Current report — wording carried from elsewhere

The following table summarizes our selling and marketing expenses for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment).

Current report — wording carried from elsewhere

The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

General and administrative expense includes employee related costs (including wages, benefits and share-based compensation expense) for general and administrative employees, external costs (including, in particular, professional fees, legal fees and costs associated with maintaining patents and other intellectual property, communications costs and IT costs, facility expenses and travel expenses) and depreciation of property and equipment and right-of-use assets.

Current report — wording carried from elsewhere

Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $25.9 million for the six months ended June 30, 2026 as compared to $25.2 million for the six months ended June 30, 2025, an increase of $0.6 million, or 2.5%. The increase was primarily related to higher accretion of our deferred royalty obligation with HCR as a result of higher total revenue, net, as well as a higher effective interest rate as a result of the HCR Amendment.

Current report — wording carried from elsewhere

Other, net consists primarily of the change in the fair value of the HCR warrant obligation, cumulative catch-up adjustments related to our deferred royalty obligation and the R&D tax credit from our UK operations. Other, net as of June 30, 2026 and 2025 included the following:

Current report — wording carried from elsewhere

On February 18, 2026, we entered into an amendment (the “HCR Amendment”) to the Purchase and Sale Agreement, dated August 25, 2021 (the “Original HCR Agreement” and, as amended by the HCR Amendment, the “Amended HCR Agreement”). In connection with the HCR Amendment, the Company issued to HCR warrants to purchase 9,834,776 common shares. The HCR warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on February 18, 2026 and is remeasured to fair value at the end of each reporting period. The fair value of the warrant obligation as of June 30, 2026 was $4.2 million. The income of $16.6 million for the six months ended June 30, 2026 was primarily due to the decrease in fair value of the underlying shares during the respective period.

Current report — wording carried from elsewhere

We are subject to corporate taxation in Switzerland and in other jurisdictions in which we operate, including the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. Under Swiss law, we are permitted to carry forward net operating losses for up toseven years, which may be used to offset future taxable income. Under U.S. tax law, research and development tax credits may generally be carried forward for up to 20 years and used to offset future tax liabilities, subject to statutory requirements. We recorded an income tax expense of nil for the six months ended June 30, 2026 as compared to $1.4 million for the six months ended June 30, 2025, primarily driven by a tax adjustment in our UK operations recorded in the comparable prior period as a result of the 2025 Restructuring.